Lead Quality Engineer Position
4 days ago
This role presents an opportunity to step into senior-level responsibilities and contribute to a high-performing regulated environment.
A leading medical device company seeks a skilled Lead Quality Engineer to lead and manage quality-related activities, drive excellence, and ensure compliance with ISO 13485 and regulatory requirements.
Responsibilities:
- Manage root cause investigations, developing corrective actions and implementing changes.
- Develop, implement, and maintain QMS procedures and policies, ensuring adherence to ISO 13485 and regulatory requirements.
- Conduct internal audits, identifying areas for improvement and driving quality enhancements.
- Oversee validation activities, ensuring process validations, test method validations, and risk assessments are completed effectively.
- Provide technical support for quality-related matters, ensuring compliance and process control.
- Collaborate with cross-functional teams to develop and implement quality initiatives.
Requirements:
- Bachelor's degree in Engineering, Quality, or Life Sciences.
- 3+ years' experience in a medical device or regulated manufacturing environment.
- Proven experience with root cause analysis, CAPA management, and failure investigations.
- Familiarity with quality engineering tools and principles, such as FMEA and SPC.
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